NCT00438945

Brief Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

First QC Date

February 20, 2007

Last Update Submit

May 5, 2008

Conditions

Outcome Measures

Primary Outcomes (3)

  • Heart rate

  • Fractional sodium excretion

  • Plasma levels of noradrenaline

Secondary Outcomes (5)

  • Fractional lithium excretion

  • Glomerular filtration rate

  • plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide

  • free water clearance

  • urinary excretion of aquaporin 2

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 65 years.
  • Body mass index less or equal to 30 kg/m2.
  • Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
  • Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

You may not qualify if:

  • History of myocardial infarction.
  • History of stroke.
  • Heart failure.
  • Endocrine organ disease.
  • Lung disease.
  • Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.
  • Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).
  • Renovascular hypertension.
  • Malignant disease.
  • Alcohol abuse.
  • Usage of medical drugs besides antihypertensives or statins.
  • Drug abuse.
  • Pregnancy or breast feeding.
  • Known intolerance or allergic to eprosartan or sodium nitroprusside.
  • Blood donation within 1 month of the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

Related Publications (1)

  • Vase H, Lauridsen TG, Graffe CC, Pedersen EB. The effect of eprosartan on reflex sympathetic activation in sodium restricted patients with essential hypertension. J Am Soc Hypertens. 2011 Sep-Oct;5(5):385-94. doi: 10.1016/j.jash.2011.03.007. Epub 2011 Jun 2.

MeSH Terms

Conditions

Essential Hypertension

Interventions

eprosartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Erling B Pedersen, MD, professor

    Department of Medical Research, Holstebro Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

January 1, 2007

Study Completion

January 1, 2008

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations